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About This Item
Full Description
This document specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigates risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
Document History
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AAMI/IEC 62366-1: 2015/(R2021) +AMD1:2020 (Consolidated Text)
Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1- Most Recent
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AAMI/IEC 62366-1:2015
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Medical devices - Application of usability engineering to medical devices- Historical Version
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AAMI/IEC 62366:2007/(R)2013
Medical devices - Application of usability engineering to medical devices- Historical Version
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AAMI/IEC 62366:2007
Medical devices - Application of usability engineering to medical devices- Historical Version
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AAMI HE74:2001/(R)2009
Human Factors Design Process for Medical Devices- Historical Version